How to Register Medicinal Products through the Centralized Procedure

Overview

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the centralized procedure. It details the products the procedure applies to and the steps that need to be considered in the pre-submission phase. Participants learn the administrative aspects of a submission and the procedural steps that need to be completed, from day 1 to day 210. The course concludes by reviewing the procedure’s decision-making process and the main post-authorization activities.

Featured Topics

Register a pharmaceutical using the centralized procedure

Who Should Attend

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives

Participants who complete this course should be able to:

Identify the legal basis and scope of the centralised procedure

Describe the procedural and administrative aspects of a submission

Clarify the aspects related to the quality section of the dossier

Outline the steps to take before the procedure commences

Review the steps and actions taken from Day 1 through Day 210 of the review process

Explore the aspects taken in the decision-making process

Identify the main post-authorization activities

The course takes an average of two hours to complete.

Contact Information

Technical Requirements

Registration Fees

Other Fees

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.